Multi Side Hole lnfusion System
FDA 510(k) clearance K953384 · decided 1995-12-22
Clearance details
- K-number
- K953384
- Device name
- Multi Side Hole lnfusion System
- Applicant
- AngioDynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-19
- Decision date
- 1995-12-22
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- QEY
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Glens Falls, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.